Kornimate/medical-research-clean huggingface dataset:
venetoclax, rituximab and ibrutinib in tn patients with cll undetectable minimal residual disease (umrd) in treatment-naïve patients with chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: this is a phase 2, multicenter, open-label uncontrolled interventional study aimed a determining therapeutic benefits of the addition of ibrutinib to 12 months of venetoclax (single-agent for 6 months then combined with rituximab for additional 6 months) in patients with treatment-naïve cll based on a mrd-guided approach. study treatment will be administered according to the following scheme: venetoclax: cycle 1 day 1-cycle 1 day 28 ramp-up with weekly dose escalation; cycles 2-12: 400 mg qd rituximab: cycle 7 day 1 375 mg/m2; cycles 8-12 day 1 500 mg/m2 at the end of cycle 12 the mrd status is checked: 3 consecutive umrd in pb + 1 umrd in bm at last assessment treatment discontinuation and follow-up at least 1 mrd+ sample in the last 3 assessments. venetoclax 400 mg qd until umrd or up to 24 months or unacceptable toxicity (whichever occurs first) in combination with ibrutinib 420 mg qd until umrd or pd or unacceptable toxicity. venetoclax will be administered orally once daily (qd) beginning with a dose-titration phase (ramp-up period). at cycle 7 day 1 rituximab will be added for up to 6 monthly cycles (cycle 7 day 1 rituximab 375 mg/m2, cycles 8-12 day 1 rituximab 500 mg/m2). at cycle 12 day 1, disease status, renal function and risk of bleeding will be assessed. minimal residual disease (mrd) will be evaluated serially in both pb and, after 3 consecutive umrd in pb, in bm. all subjects with umrd (defined as those with mrd level \ 10-4) and patients with stable disease without any contraindications to ibrutinib will start treatment with ibrutinib. ibrutinib will be administered at the standard dose in cll (i.e. 420 mg qd). venetoclax will be administered until confirmed umrd (3 consecutive umrd in pb, the last one with concomitant umrd in bm), unacceptable toxicity or disease progression or for a maximum of 2 years and ibrutinib will be continued until unacceptable toxicity, confirmed umrd or disease progression.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years but \<65 years 2. active cll/sll requiring treatment per iwcll 2018 criteria 3. no previous therapy for cll/sll 4. adequate bone marrow function: 1. anc ≥1.0 x 109/l; 2. plt ≥25 x 109/l; 3. hgb ≥8.0 g/dl exclusion criteria: 1. any prior therapy used for treatment of cll or sll 2. history of other malignancies, except in situ carcinoma or malignancy treated with curative intent 3. known or suspected history of richter's transformation 4. known hypersensitivity to one or more study drugs 5. inadequate renal function: crcl \<30 ml/min 6. uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia 7. requires the use of warfarin or derivatives 8. treatment with any of the following within 7 days prior to the first dose of study drug: 1. steroid therapy for anti-neoplastic intent 2. moderate or strong cytochrome p450 3a (cyp3a) inhibitors (see appendix g for examples) 3. moderate or strong cyp3a inducers (see appendix g for examples)
safety study of peptide cancer vaccine to treat hla-a*24-positive advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of hla-a\*2402 restricted epitope peptides urlc10, cdca1, and kif20a emulsified with montanide isa 51 for advanced non-small cell lung cancers.

the investigators previously identified three novel hla-a\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, urlc10, cdca1, and kif20a, as targets for cancer vaccination against lung cancer. in this phase i trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for hla-a\*2402-positive advanced non-small cell lung cancer patients who failed to standard therapy.

Eligibility criteria:
inclusion criteria: 1. nsclc that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy 2. ecog performance status 0-2 3. age between 20 to 85 4. clinical efficacy can be evaluated by some methods 5. no prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks 6. life expectancy \> 3 months 7. laboratory values as follows 1500/mm3 \ 75000/mm3 asparate transaminase \< 3 x cutoff value alanine transaminase \< 3 x cutoff value total bilirubin \< 3 x cutoff value serum creatinine \< 2x cutoff value 8. hla-a\*2402 9. able and willing to give valid written informed consent exclusion criteria: 1. active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. myocardial infarction within six months before entry 3. breastfeeding and pregnancy (woman of child bearing potential) 4. active and uncontrolled infectious disease 5. concurrent treatment with steroids or immunosuppressing agent 6. other malignancy requiring treatment 7. non-cured traumatic wound 8. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: urlc10 cdca1 kif20a lung cancer vaccine hla-a*2402
gastroesophageal reflux disease (gerd) segmentation: document how swiss general practitioners (gps) allocate their gerd patients to the three gerd patient segments

Conditions: GERD

Summary: document how swiss gps allocate their gerd patients to the three gerd patient segments (according to king et al.) and how treated gerd patients are affected by their gerd treatment


Eligibility criteria:
inclusion criteria: * previously diagnosed gerd patients * on treatment for at least 2 weeks exclusion criteria: * none

Keywords: gerd pharmacoepidemiology
efficacy of cryoballoon focal ablation system on human esophageal barrett's epithelium

Conditions: Barrett's Esophagus

Summary: the purpose of this study is to assess the efficacy and performance of the c2 focal cryoablation system in patients with be.

the purpose of this study is to assess the efficacy and performance of the c2 focal cryoablation system in patients with be. the study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible be using the c2 system focal ablation system. length of ablation will be 10 seconds. the ablations will be performed on barrett's epithelium with a maximal length of 6 cm. at the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to histopathology protocol. this study is: * prospective * multi-center * non-randomized

Eligibility criteria:
criteria inclusion criteria * patients with known barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed. * patient is 18 to 80 years of age at the time of consent (inclusive). * patient has provided written informed consent (ic) using an informed consent form (icf) that has been approved by the institution's reviewing irb/ec. * patient is willing and able to comply with all clinical investigation plan (cip) requirements. * patient is deemed operable per standard institutional criteria. * be lesion length \<6cm excluding visible be islands, and prague classification c ≥ 0 / m ≥ 0. * one of the following: flat lgd, flat hgd, residual be after emr for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), residual be after a single circumferential rfa (performed for indications listed above: i-iii) * be lesion within the treatment zone should be flat exclusion criteria * esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone. * patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines. * patient refuses or is unable to provide written informed consent. * patients that are pregnant. * patient with endoscopically active inflammation in the treatment zone. * endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
extended resection for rectal cancer with neoadjuvant radiotherapy

Conditions: the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy

Summary: preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. however, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. according to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. however, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.


Eligibility criteria:
inclusion criteria: 1. patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus); 2. the preoperative local stage is ct3-4n0-2m0 or ct3-4n0-2m1 (m1 is limited to liver metastases that can be surgically removed at the same time) 3. preoperative neoadjuvant therapy (long-course concurrent chemoradiation or tnt) 4. aged between 18-75 years old; 5. asa rating: 0-2 6. ecog score: 0-2 7. bmi 18-30 kg/m2; 8. radical surgical resection is expected to be possible on the basis of preserving the anus; 9. sign the informed consent document. exclusion criteria: 1. history of other malignant tumors; 2. emergency surgery patients; 3. severe underlying diseases, unable to tolerate surgery; 4. without informed consent.
motorised probe holder assisting prostate biopsies

Conditions: Prostate Cancer

Summary: study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.


Eligibility criteria:
inclusion criteria: * of-age patient * patient for whom a prostate biopsies session is planned * patient affiliated to the social security or equivalent * patient having a target identified on mri * written informed consent exclusion criteria: * contraindication * patient wearing a mechatronic device * patient concerned by the l1121-6 à 8 of the health public code

Keywords: prostate cancer
irreversible electroporation(ire) for unresectable laryngeal neoplasms

Conditions: Laryngeal Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable laryngeal neoplasms.

by enrolling patients with unresectable laryngeal neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable laryngeal neoplasms.

Eligibility criteria:
inclusion criteria: * laryngeal neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable laryngeal neoplasms
upar-pet for prognostication in patients with non-small cell lung cancer, malignant pleural mesothelioma and large cell neuroendocrine carcinoma of the lung

Conditions: Non-small Cell Lung Cancer; Malignant Pleural Mesothelioma; Large Cell Neuroendocrine Carcinoma of the Lung

Summary: upar pet/ct as a prognostic marker in non-small cell lung cancer.

study i: upar pet/ct with 68ga-nota-ae105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (nsclc) (stage iv (ia) operable disease (ib)) by observer-blinded readings and compared to the prognostic performance of fdg pet/ct and prognostic biomarkers as upar. furthermore, upar pet/ct will be evaluated in a pilot study in patients with malignant pleural mesothelioma (mpm) (study ii) and large cell neuroendocrine carcinoma of the lung (lcnec) (study iii) and correlated with immunohistochemical upar expression.

Eligibility criteria:
inclusion criteria: study i * histologically verified nsclc (study i) * stage iv disease * operable disease * the participants must be capable of understanding and giving full informed written consent study ii * histologically verified mpm (study ii) * the participants must be capable of understanding and giving full informed written consent study iii * histologically verified lcnec (study iii) * the participants must be capable of understanding and giving full informed written consent exclusion criteria: study i, ii, iii * pregnancy * lactation/breast feeding * treatment with neoadjuvant chemotherapy * weight above 140 kg * allergy to 68ga-nota-ae105
antibiotic prophylaxis in children with pyelonephritis

Conditions: Pyelonephritis

Summary: children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. the focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. this study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.


Eligibility criteria:
inclusion criteria: * children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux. * acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) cfu/ml for catheterization specimens and =10(4) cfu/ml for clean catch specimens), and a positive dmsa scan (a discreet defect or generalized decrease in activity). exclusion criteria: * neurogenic bladder * anatomic congenital anomaly * allergy to all prophylactic antibiotics * children whose parents do not wish to participate

Keywords: pyelonephritis pediatric pyelonephritis vesicoureteral reflux dmsa scan
a new telemedicine approach for chronic hiv/aids patient home care

Conditions: HIV Infection

Summary: background: antiretroviral therapy has changed the natural history of the hiv infection in developed countries becoming a chronic disease. this clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. a new home care model using a telemedicine system (virtual hospital) was developed.

stable hiv-infected patients with access to a computer and broadband were randomized to: arm i, patients monitored by virtual hospital the first year and arm ii patients monitored in the hospital the first year (standard of care). after 1 year of follow up, patients were crossed into the other arm. a "virtual hospital" was developed to integrate the control of patient in a multidisciplinary telecare team, allowing the patient to be remotely followed-up by the healthcare professionals through internet. virtual hospital had four main services: virtual consultations, telepharmacy, virtual library and virtual community. a technical and a clinical evaluation of virtual hospital were made.

Eligibility criteria:
inclusion criteria: * stable patients (cd4 \>250 cells/mm3 during at least the 3 months before inclusion to the study) * having access to a computer and to a broadband exclusion criteria: * hiv infected adults with current therapy failure (defined by detectable viral load on treatment or cd4 cell count \< 250 cells/ml) * tumors * opportunistic infections * pregnant women

Keywords: telemedicine home care chronic hiv infection hiv-infected patients
effect of air-stacking on peak cough flow in patients with acute cervical or high thoracic spinal cord injury

Conditions: Spinal Cord Injury; Tetraplegia

Summary: respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. the prevention of these respiratory complications needs to begin immediately after injury. to achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. the emphasis should therefore be on expansion of the lungs before coughing. one way of expanding the lungs is by air-stacking. in air-stacking insufflations are stacked in the lungs to maximally expand them. cough can be valued by measuring peak cough flow (pcf). by combining air-stacking with manually assisted cough the pcf can be increased sufficiently. the aim of this study is to compare the effect of two different air-stacking techniques on pcf, air-stacking on a respirator versus air-stacking with a manual resuscitator.


Eligibility criteria:
inclusion criteria: * acute cervical or high thoracic spinal cord injury admitted to the icu exclusion criteria: * substantial abdominal or thoracic injury * substantial brain damage * intubated or tracheostomized patients * not able to cooperate * pregnant women

Keywords: respiratory complications respiratory insufficiency respiratory therapy
human phototoxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a health insurance portability and accountability act (hipaa) authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product; * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;
efficacy and safety of bromfenac ophthalmic solution

Conditions: Cataract Surgery

Summary: this is a safety and efficacy study of bromfenac ophthalmic solution


Eligibility criteria:
inclusion criteria: * male or female greater than or equal to 18 years of age, and scheduled for cataract surgery exclusion criteria: * active corneal pathology in either eye
an open label phase ii study combining nivolumab and celecoxib in patients with advanced " cold " solid tumors

Conditions: Metastatic Cancer

Summary: this is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib. the total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * measurable disease as per recist 1.1. * adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation. * metastases biopsiable on two occasions * recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. in order to include only ido1 positive (≥5% expression of tumor cells) and non t-cell infiltrated tumors (\<1% t cells infiltrating the tumor bed) * cancer types with an indication of treatment with anti-pd1 antibodies such as * melanoma non braf mutated in first line of treatment * melanoma braf mutated in first or second line of treatment * lung cancer (nsclc) in second line of treatment * renal cell cancer (rcc) in second line of treatment * head and neck squamous carcinoma (hnsc) after platinum salt based chemotherapy * bladder cancer after platinum salt based chemotherapy exclusion criteria: * active brain metastases or leptomeningeal metastases. * ocular melanoma. * subjects with active, known or suspected autoimmune disease. subjects with vitiligo, type i diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other autoimmune condition not expected to recur in the absence of an external trigger are permitted to enroll. * subjects must also meet other study criteria including exclusions for medical history, positive hep b/c, hiv, and pregnancy tests, and other laboratory criteria.

Keywords: nivolumab celecoxib